SOO Chemistry 2025.pdf

STATEMENT OF OBJECTIVES

The successful offeror shall furnish all chemistry analyzers, immunoassay analyzers and automated specimen track system including any necessary maintenance services, supplies and reagents needed to perform automated specimen processing to the Department of Clinical Laboratory and Pathology Services, Keesler Air Force Base Medical Center, Keesler Air Force Base Mississippi. All analyzers, automated specimen track system and bidirectional vendor supplied computer interface must have ability to connect to and be fully interoperable with Cerner Military Health System (MHS) Genesis Lab Information System. Training for all equipment, software and accessories will be provided by the vendor at no additional charge to the government. This requirement will be met via equipment rental/lease or on a Cost Per Reportable Result (CPRR) basis. Analyzers must be in place and fully operational i.e. ready for patient testing to include MHS Genesis build and validation and be approved by the Laboratory Director to begin patient testing by the start of the base year period of performance. In addition, an approved authorization to operate (ATO) is required prior to use and any subsequent billing. ATO approval must be maintained and valid through the life of the contract. Vendor must include Utility layout required and CAD drawing with detailed analyzer layout with proposal.

Period of Performance:

Base: 1 October 2025 – 30 September 2026 (CLIN 0001 and subCLINs) Option 1: 1 October 2026 – 30 September 2027 (CLIN 1001 and subCLINs) Option 2: 1 October 2027 – 30 September 2028 (CLIN 2001 and subCLINs) Option 3: 1 October 2028 – 30 September 2029 (CLIN 3001 and subCLINs) Option 4: 1 October 2029 – 30 September 2030 (CLIN 4001 and subCLINs)

1. Authorization to Operate (ATO) (Subfactor 1A)

1.1. Analyzers must have a bi-directional interface that can connect to and be fully interoperable with the laboratory information system and have an approved ATO as listed on CSTAR (https://info.health.mil/apps/HIT/cstar/Pages/Systems.aspx) prior to use and any subsequent billing. ATO approval must be maintained and valid through the life of the contract.

1.2. Middleware must have an approved ATO prior to use and any subsequent billing, and approval must be maintained and valid through the life of the contract.

1.3. Each interface shall allow for recognition and interpretation of MHS Genesis generated bar-code labels on all sample tube types. Connectivity between the Vendor instrument systems and middleware to each LIS will be required at varying times during the contracted period of performance. Location: 81MDTS/SGQC Clinical Laboratory, Keesler Medical Center, Keesler Air Force Base, MS.

2. Instruments/Equipment and Reagents/Consumables (Subfactor 1B).

2.1. Chemistry /Special Chemistry analyzers shall meet the following minimum requirements:

2.1.1. Supply two floor standing integrated clinical chemistry /immunoassay analyzers with discrete random access of patient specimen, Reagents, Calibrators, Controls, and Consumables.

https://info.health.mil/apps/HIT/cstar/Pages/Systems.aspx

2.1.2. Capable of processing the full chemistry and immunoassay test menu performed at Keesler AFB, listed in section 5 with all reagents needed to perform the total of all patient results specified for each fiscal year. Allowing for Mirror image analyzer backup with capability of running the full test menu.

2.1.2.1. If the Vendor’s automated system does not offer FDA approved test performed at Keesler AFB listed in section 5, Vendor will provide an alternate FDA approved bench top test at vendor’s expense.

2.1.3. The entire system shall have an approved ATO for remote connections (internet, cloud, etc.) to be functional and serviceable.

2.1.4. Will have sample and reagent bar-code reading capability.

2.1.5. Will have On-board test auto inventory, automatic dilution of patient samples and user configurable automatic rerun/reflex.

2.1.6. Will have Short Sample, Clot, and Bubble Detection.

2.1.7. Will have Hemolysis, Lipemia and Icteria detection with no impact on sample throughput.

2.1.8. Will have the ability to perform all tests in inventory with no manual sample pretreatment or predilution for any assay including whole blood or urine specimen.

2.1.9. All analyzers will connect to automated track system and be fully interoperable with MHS Genesis.

2.1.10. Will have 90% of reagents ready-to-use requiring limited preparation.

2.1.11. Will have On Board Maintenance Records.

2.1.12. Will have a Quality Control, Linearity and Precision program that will meet College of American Pathologist (CAP) requirements. Ability to program quality control ranges, calibration set points and system parameters without stopping or pausing the system.

2.1.13. Will have a Quality Control program which has Bar-code identification with the ability to use third party bar-coded control material, Ability to setup, process and correlate multiple quality control lots simultaneously.

2.1.14. Shall have the ability to continually load and unload bar-coded liquid third party quality control material at any time, store at least 50% of liquid controls on the system, and automatically run liquid controls at user-defined intervals.

2.1.15. Shall have 90% of calibrators are liquid ready for use.

2.1.16. Shall have the ability to continually load and unload bar-coded calibrators at any time, store at least 50% of liquid calibrators on the system and automatically run liquid calibrators at user-defined intervals.

2.1.17. Shall have the ability to correlate reagent lot to lot runs by having simultaneous lots on board the analyzer.

2.1.18. Reagents must be designed to allow for error proof loading. Safety measures must be in place preventing capped reagent loading errors such as failure to remove cap causing probe crash.

2.1.19. Error free reagent loading where Bulk reagents are keyed and color coded for designated locations.

2.1.20. Chemistry/Immunoassay analyzers must have the capability to interface and be fully interoperable with the laboratory information system (LIS), MHS Genesis.

2.1.21. Chemistry/Immunoassay analyzers must have an approved authorization to operate (ATO) on the DHA network in order to interface with the LIS. Refer to CSTAR list (https://info.health.mil/apps/HIT/cstar/Pages/Systems.aspx). In addition, an approved authorization to operate (ATO) is required prior to use and any subsequent billing. ATO approval must be maintained and valid through the life of the contract.

2.2. Automation will meet the following minimum requirements:

2.2.1. Supply one floor standing continuous loop automated track system.

2.2.2. Process multiple tube sizes.

2.2.3. Process multiple sample tube types from multiple tube suppliers. Tube types include lithium heparin tubes (Green Cap), serum tubes (Red or Gold Cap), urine tubes (White Cap), EDTA tubes (Purple Cap) and Oxalate tubes (Grey Cap).

2.2.4. Ability to identify sample tube type by tube cap color and analyze tube type for proper patient testing.

2.2.5. Connect and interface with all analyzers offered.

2.2.6. Front end processing to include sample priority sorting with a single input and output module.

2.2.7. A centrifuge located on the track system.

2.2.8. Automatic sample rerun and reflex.

2.2.9. On-board test auto inventory.

2.2.10. Processing to include:

2.2.10.1. On-board recapping/sealing

2.2.10.2. On-board decapping/desealing.

2.2.11. Adequate number of trays to be used for archiving capabilities.

2.3. Reagents/Consumables.

2.3.1. Vendor will supply all consumables, parts and accessories needed by the analyzers to function and process all patient testing.

2.3.1.1. The vendor shall provide all reagents/reagents packs, calibrators/standards, calibration verification materials, quality control materials, user-replaceable maintenance items, consumables, accessories, and analyzer specific tools/supplies to support the ongoing delivery of laboratory services using the equipment outlined in this section.

2.3.1.2. Materials must meet the College of American Pathologist (CAP) requirements.

2.3.2. The Vendor shall provide paper and electronic copies of safety data sheets (SDSs) for each reagent item delivered under this contract (as appropriate).

2.4. Middleware network must have:

2.4.1. Middleware must have an approved ATO to operate on the DHA network and interface with the LIS. Refer to CSTAR (https://info.health.mil/apps/HIT/cstar/Pages/Systems.aspx In addition, an approved authorization to operate (ATO) is required prior to use and any subsequent billing. ATO approval must be maintained and valid through the life of the contract.

2.4.2. A middleware system with 4 additional computers with points of access to the middleware network.

2.4.3. Usage of all computer components, printers and accessories needed to operate instruments, middleware, and track system.

2.4.4. The entire system shall have an approved ATO for remote connections (internet, cloud, etc.) to be functional and serviceable. Middleware will be on a physical server provided and maintained by vendor.

2.4.5. All software updates or file exchange shall be completed using CD/DVDs only. At no time will USB, internet or cloud-based services be allowed.

2.4.6. Turn-key operation where all user configurable auto-validation, auto-reflex of results using either internal rulesets or user-defined auto-reflex parameters, normal ranges, linear ranges, panic values, delta checks, instrument errors, calculated tests shall be written, tested, and validated by the vendor.

2.4.7. The system shall have a comprehensive quality control software or provide a 3rd party vendor quality control software program approved by Keesler AFB Medical center that includes, test lockout when Quality Control falls out of range, ability to assess quality controls using Westgard rules, the ability to use third party bar-coded control material, Quality Control timeout, Ability to setup, process and correlate multiple quality control lots simultaneously and on board or access to a quality control statistical program to include Daily/monthly Levy-Jenning’s quality control graphs available for review and printing or saving to backup disks.

2.5. Peripherals

2.5.1. Vendor shall include at a minimal, Uninterruptable Power Sources (UPSs), electrical line conditioners as required, instrument-specific computer terminals/CPUs; Printers shall include at a minimal, initial toner for each as needed, Reagent Grade Water system, Air Compressor and other equipment where required.

2.5.2. Each analyzer, including printer, monitor, UPS, and computer system, shall fit within the dimensions outlined in section 1.6. and complete operations on one platform. Sufficient room for proper exhaust and heat clearance based on manufacture’s site specifications shall be maintained, with at minimum a 36” clearance between the existing wall and instruments. Any sliding compartments or access drawers for servicing cannot extend beyond the width of each individual unit outlined in figure below when fully expanded.

2.6. Lab Layout.

2.6.1. The Vendor shall provide a diagram or other graphical representation demonstrating proposed equipment fitment within the dimensions with the proposal. NOTE: A floor drain (1), and dedicated water system is available. (See current layout – attachment 1).

2.6.1.1. Vendor shall provide two diagrams or other graphical representations demonstrating proposed equipment fitment within the dimensions listed below for final placement (1of 2) and another for fitment during the validation period (2 of 2).

2.6.2. The Vendor shall provide a diagram or other graphical representation demonstrating temporary and permanent plumbing, water supply, power supply and other equipment required with quote (i.e. facility modification requirements).

2.6.3. The Vendor shall meet the following facilities requirements:

2.6.3.1. Space:

• Ceiling Height: 95”

• Door opening: 82”

• Floor Space availability: 36’ x 12’6”

2.6.3.2. Circuit availability:

• 2ea 208V 30AMP

• 6ea 110V 15AMP

2.6.3.3. Water and Drain availability:

• 1ea DI water lines 30L/HR. 7-57 PSI with 1/2' barbed hose

• One 2” Drain

2.6.3.4. HVAC:

• Total CFM 2919

• Area Heat load capability 33K BTU/hr

3. Service and Maintenance (Subfactor 1C). The Vendor shall meet the following service and maintenance requirements for all testing locations at Keesler AFB Medical Center.

3.1. The Vendor shall provide direct customer service and support, 24 hours/7 days a week, to include hotline telephone service (provided in English) and on-call on-site emergency repair, to assist operators in correcting equipment problems. Emergency repair includes but is not limited to malfunction of both analyzers during the same period, malfunction that may cause a safety issue, etc.

3.2. The Vendor will maintain all equipment installed under this contract. This includes emergency repairs as well as routine Preventive Maintenance Services (PMS), safety tests, calibrations/calibration verifications, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

3.3. The Vendor shall provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level shall be performed by Vendor service personnel in accordance with requirements as specified in the Vendor’s instrument maintenance manual. Completion of analyzer installation will establish time-zero for determining the time frame for performance of periodic services.

3.4. Any service technician provided by the Vendor shall adhere to all required reporting procedures for Keesler AFB Medical Center prior to reporting to the laboratory for work. Current procedures will be made available.

3.5. For equipment supporting the Laboratory, the service technician shall be on-site to provide unlimited service within twenty-four (24) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial on-site response by the Vendor.

3.5.1. Should all analyzers become inoperable, the Vendor’s service technician shall be on-site within four (4) hours of initial notification. The repair of at least one (1) analyzer shall be completed within eight

(8) hours of initial notification.

3.6. In all cases, the Vendor shall provide all reagents, calibrators, controls, and any other materials necessary to troubleshoot instrument failure. Replacement parts used, as necessary, claimed from local operator-level maintenance kits as well as any reagents that may have been used shall be replaced at no cost by the Vendor.

3.7. The Vendor shall schedule the date and time for performance of a preventive maintenance service no later than ten (10) days prior to the scheduled preventive maintenance services.

3.8. Within one (1) working day after completion of a repair, the Vendor’s representative shall furnish the one (1) copy of a service report for all services performed with a copy to the Equipment Management Branch and the Laboratory Representative for the Keesler AFB Medical Center. The report shall be in English and shall contain, as a minimum, the following information:

- Nomenclature and serial number

- Date of service

- Description of services performed (i.e., preventive maintenance service, or unscheduled repair service)

- Location of services performed

- Duration of performance (hours)

- List of parts replaced or other actions taken to restore operability of the instrument

- Name of technician

3.9. The Vendor shall relocate/revalidate any instrument if requested by the Government at no additional cost. This includes any location within the Keesler AFB Medical Center.

3.10. Shall provide product service and support to include updates to operational software throughout the lifecycle of the equipment.

4. Training (Subfactor 1D).

4.1. The Vendor will provide the training for each piece of equipment, including the track system, at no additional cost to the Government. The following will be provided at Vendor expense: lodging (hotel), per diem, and travel (airfare, local transportation) expenses to/from Keesler AFB, hotel, and training location (offsite location). Additional training, upon request, for one operator per year per instrument (lodging (hotel), per diem, and travel (airfare) expenses included to/from Keesler AFB, hotel, and training location).

4.2. Training shall include basic analyzer operation, troubleshooting procedures, performance of operator level periodic preventive maintenance procedures and use any data management/quality control software.

4.3. The Vendor shall provide initial operator training to assigned technicians at Keesler Medical Center prior to implementation of the analyzer for patient testing.

4.4. The Vendor shall provide training for two (2) primary (key) operators, per analyzer prior to implementation of the analyzer. This training will be off-site at the Vendor’s expense. Alternative training delivery (i.e., distance training), if determined by the Government customer to be of equivalent quality, may be entertained in lieu of offsite, in-person training for non-initial training.

4.5. Upon renewal of the option years and in the case of any significant software or assay procedural updates, the Vendor shall provide one (1) primary (key) operator training slot per analyzer. This training will be on-site at the Vendor’s full expense.

5.6. If training for the automated track system is separate from the analyzer training, Vendor to provide initial track system training for 2 laboratory personnel and annual track system training for 1 laboratory personnel. Training may be conducted on-site or off-site at the Vendor’s full expense.

5. Delivery and Installation (Subfactor 1E).

5.1. All systems shall be delivered to the appropriate location indicated below.

Keesler Air Force Base Medical Center Pathology and Laboratory Department 301 Fisher St.

Keesler AFB, MS 39554

5.2. Vendor to provide a project manager to perform/oversee system installation, correlation, and validation. Vendor also to provide all validation reagent/materials needed to perform these tasks at Vendor’s expense. During the initial implementation, a primary, dedicated Clinical Application Specialist shall be assigned and available on site throughout the entire implementation period. Substitutions shall be coordinated with and approved by Keesler Medical Center.

5.3. No less than 10 calendar days from the contract award, vendor shall coordinate and conduct a post-award site visit for the purpose of coordinating the schedule for equipment installation and validations.

5.3.1. The Project Manager will provide a timeline identifying critical points in the delivery/installation phase, wherein Day 0 = Notice of Award.

5.3.2. Contract must include instrument installation, set-up, validation, supplies, and labor. Instruments must be installed, validated and ready for patient testing by the start of the base year of the period of performance. The on-site installation process should begin no less than 90 days after award, but as soon as necessary to ensure equipment is fully operational on first day of the base year of the period of performance.

5.4. The Vendor shall provide a qualified Clinical Application Specialist, who possesses a thorough knowledge of method validation/verification and, where applicable, is familiar with the use of clinical laboratory statistical valuation software (e.g. EP Evaluator®), to provide technical assistance for the method validation/verification studies. The assigned Clinical Application Specialist will be responsible for the entire method validation to the standards of the acting medical director. Additional Clinical Application Specialists may be brought in to assist in method validations/verifications.

5.5. Method validation/verification will be completed by qualified Clinical Application Specialists within two weeks of analyzer and component installation and functionality and will be conducted in accordance with Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and the College of American Pathologists (CAP) requirements.

5.6. Method validation/verification will include, but not be limited to normal range (reference interval) verification, verification of reportable range (AMR), correlation to current methods, verification of precision, carryover studies and establishment of initial ranges using control materials, to include third party controls as required.

5.7. Once completed, the method validation/verification must be approved by the Laboratory Director prior to reporting of patient results. Payment for services will not begin until the analyzer system has been approved for reporting of patient results.

5.8. All instrument reagents, calibrators, linearity materials and other required reagents/materials used in the method validation/verification study will be provided by the Vendor at no additional cost to the Government.

6. Test Menu

6.1. The table below lists the tests required with estimated number of tests per year. It is estimated that the volume for each test may either decrease or increase by 5 percent each year.

6.1.1. The Government will order items on as-needed basis and shall only pay for the actual number of tests ordered, received, and accepted by the Government. The quantities listed herein represent anticipated test volumes for the period of performance listed.

6.2. The Vendor will perform validation requirements in accordance with CLIA regulations and CAP standards for newly added tests when requested by the Government and at Vendor’s expense.

6.2.1. The Vendor will assist the laboratory in performing additional test validations to meet CAP requirements for validating test modification such as those that were not part of the original manufacture’s test validations such as, but not limited to, neonatal populations.

6.2.1.1. The vendor will provide all materials (e.g. specimens and reagents) required for said validations.

GENERAL CHEMISTRY Base Year Estimated number of Tests/Year

ALANINE AMINOTRANSFERASE (ALT) 17,498

ALBUMIN 36,205

ALKALINE PHOSPHATASE (ALP) 16,972

AMMONIA 117

AMYLASE 222

ASPARTATE AMINOTRANSFERASE (AST) 17,693

BLOOD UREA NITOGEN 34,060

CALCIUM 33,793

CARBON DIOXIDE 33,513

CHOLESTEROL 8,994

C-REACTIVE PROTIEN 1,817

CREATINE KINASE - TOTAL 536

CREATININE 44,130

DIRECT BILIRUBIN 2,917

ETHANOL (ETOH) 451

GAMMA-GLUTAMYL TRANSFERASE 328

GLUCOSE 34,928

GLYCOCYLATED HEMAGLOBIN A1C 10,754

HIGH DENSITY LYPOPROTIEN - DIRECT 8,978

IRON (NO PRETREATMENT) 5,370

LACTATE 1,702

LACTIC DEHYDROGENASE 697

LIPASE 2,420

LOW DENSITY LYPOPROTIEN - DIRECT 8,982

MAGNESIUM 10,568

PHOSPHOROUS 15,468

PREALBUMIN 103

TOTAL BILIRUBIN 17,367

TOTAL PROTEIN 17,029

TOTAL/ UNSATURATED IRON BINDING CAPACITY 5,376

TRANSFERRIN 5,307

TRIGLYCERIDE 9,044

URIC ACID 1,433

ELECTROLYTES

CHLORIDE 39,084

POTASSIUM 39,084

SODIUM 39,084

IMMUNOCHEMISTRY

25-OH, VITAMIN D 6,948

3RD GENERATION THYROID STYMULATING HORMONE (TSH) 8,623

B12, VITAMIN 3,081

Beta HUMAN CHORIONIC GONADOTROPIN (Beta- HCG) 998

CORTISOL 267

ESTRADIOL 299

FERRITIN 3,674

FOLATE 3,081

FOLLICLE STIMULATING HORMONE (FSH) 489

FREE THYROXINE (FT4) 4,030

INSULIN 158

LUTEINIZING HORMONE (LH) 489

PROCALCITONIN 263

PROGESTERONE 138

PROLACTIN 860

RAPID/INTACT PARATHYROID HORMONE (PTH) THAT IS

INTRAOPERATIVE CAPABLE

2,041

TOTAL TESTOSTERONE 433

TRIIODOTHYRONINE (FREE T3) 312

URINE DRUGS OF ABUSE

AMPHETAMINE 1,028

BARBITURATE 1,028

BENZODIAZEPINE 1,028

CANNOBINOID 1,028

COCAINE 1,028

OPIATE 1,028

PHENCYCLIDINE 1,028

IMMUNONOLOGY

ANTI STREPTOLYSIN O (ASO) 27

IMMUNOGLOBULIN A 262

IMMUNOGLOBULIN G 227

IMMUNOGLOBULIN M 227

RHEUMATOID FACTOR (RF) 378

THERAPEUTIC DRUGS

ACETAMINOPHEN 297

CARBAMAZEPINE 30

DIGOXIN 59

GENTAMICIN 24

LITHIUM 50

PHENOBARBITAL 31

PHENYTOIN 27

SALICYLATE 254

TOBRAMYCIN 21

THEOPHYLLINE 23

VALPORIC ACID 62

VANCOMYCIN 250

Tumor Markers

3RD GENERATION TOTAL PROSTATE SPECIFIC ANTIGEN (PSA) 2,576

ALPHA FETAL PROTIEN 212

CA-125 ANTIGEN 95

CARCINOEMBRYONIC ANTIGEN (CEA) 231

FREE PROSTATE SPECIFIC ANTIGEN (PSA) 458

URINE CHEMISTRY

MICROALBUMIN 8,119

URINE TOTAL PROTEIN/ CSF TOTAL PROTEIN 2,103

CARDIAC TESTS

CREATINE KINASE - MUSCLE BRAIN 84

HIGH SENSITIVEITY TROPONIN I 4,936

HIGH SENSITIVITY C-REACTIVE PROTIEN 135

N TERMINAL-PRO BRAIN NATRIURETIC PEPTIDE 2,244

Total # of tests annual 588,843

ATTACHMENT 1